The impact of vaccination on acquisition of vaccine and nonvaccine HPV types 24 and 48 weeks after initial vaccination among those who seroconvert. [ Time Frame: Weeks 24 and 28 ] [ Designated as safety issue: No ]

Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Biological: HPV vaccine for strains -6, -11, -16, and -18

All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Active Comparator: B

Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Biological: HPV vaccine for strains -6, -11, -16, and -18

All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Eligibility

Ages Eligible for Study:

16 Years to 23 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Young women age 16 years and 0 days to 23 years and 364 days

HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA > 1,000 copies/ml

HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on ARV medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.

Anticipated ability and willingness to complete all study vaccines and evaluations

Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

History of any prior vaccination with an HPV vaccine

Active anogenital warts within three months prior to study entry) or history of CIN 2/3 (ever, must be documented by colposcopy)

Previous allergic reaction to any constituents of the HPV vaccine

Pregnancy

Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study

Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry

Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the ATN Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).

Receipt of any routine vaccine within four weeks prior to study entry

Receipt of any immune globulin or plasma product within six months prior study entry

Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry

Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry

Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry

Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection

Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria

Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy

If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710593